Specialist in pharmacokinetics with over 19 yr of experience in pharmaceutical industry as pharmacokineticist: at Active Biotech AB (Lund), Novo Nordisk A/S (Copenhagen), senior consultant at Semcon Caran AB (Stockholm) and since March 2013 as independent consultant. As consultant, various assignments in more than 20 companies developing both small molecule drugs and biologics. Degree in Chemistry and a PhD in kinetics and toxicology (Karolinska Institute and National Institute of Working Life) and post-doc studies (Institute of Occupational Health, Switzerland) within the fields of pharmacokinetics (PK), drug metabolism (DM), toxicology, and bioanalysis. Supporting nonclinical and clinical programs with PK expertise as well as PK aspects during Due Diligence, covering all development phases from drug discovery until regulatory filing for market authorization. Additional training in quality assurance (QA) activities, including audits, SOP and implementation of good laboratory practice (GLP). More than 10 publications in peer-reviewed papers as well as risk assements. Physiological based pharmacokinetic modelling (PBPK), PKPD analysis as well as simulations. Software: mainly using Phoenix WinNonlin and Berkeley Madonna
Achim Orzechowski, PhD, CSO
Specialist in Drug Metabolism and Pharmacokinetics. Degree in Chemistry and a PhD in Toxicology from the University of Tübingen in Germany, published more than 20 peer-reviewed articles. R&D Scientist & Manager with over 20 years of industry experience in drug discovery & development. Holder of senior management positions in AstraZeneca R&D leading the Drug Metabolism & Pharmacokinetics department in Södertälje for more than 6 years. Management of a portfolio of drug discovery programs in the CNS area in AstraZeneca, with significant experience of external collaborating both across national and cultural barriers as well as DM aspects during Due Diligence. In depth experience in evaluating drug discovery & development programs for in-licensing including performing due-diligence. Strong background in strategic R&D management, portfolio evaluation and licensing of programs in stages from early discovery to Phase 2 clinical trials.
Anja Broeders, BSc, QA
Senior Quality Advisor and GLP Auditor with over 25 years experience from the Pharmaceutical and Medical Device Industry, with focus the last twelve years on quality assurance, e.g. internal and external audits, quality advice to R&D functions and global projects. Significant experience from hosting regulatory inspections, including FDA. In addition, a long experience in training of personnel and students in the quality aspects of laboratory work. Extensive knowledge in GLP, GMP and GCP, and other related standards as well as QA aspects during Due Diligence.